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Janssen Single-Dose COVID-19 Vaccine is Pending FDA Emergency Use Authorization

  • by Steve Nesnidal, MD, CPC, AHFI
  • Feb 23, 2021, 09:34 AM

UPDATE: FDA Grants EUA for Janssen COVID-19 Vaccine

On February 27, 2021, the FDA granted Emergency Use Authorization (EUA) for Janssen's investigational single-dose COVID-19 vaccine. 

Subsequently, the FDA put a hold on the EUA on April 13th, to investigate an association of rare blood clots with the administration of this vaccine. 

The EUA was restored ten days later, on April 23rd, with revisions to the vaccine's fact sheet. Warning information was added about reports of adverse events of Thrombosis with Thrombocytopenia that occurred in some patients (mostly females between ages 18-49 years), approximately 1-2 weeks after they received the vaccine. This was fatal in some cases. 

The revision includes some treatment information for healthcare providers who treat such patients: 
Informing against use of heparin to treat this adverse event. 
A link to published considerations from American Society of Hematology related to treating this adverse event. 

See revised fact sheet for the Janssen COVID-19 Vaccine.

On February 4,  2021, Janssen Biotech, Inc. applied to the FDA for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine. The vaccine’s safety and efficacy data, among other info, will be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a meeting scheduled for February 26.

Janssen Vaccine Might Be a Necessary Bullet in the Global Fight Against COVID-19

The vaccine has several pertinent characteristics that suggest in may be highly desirable in fighting COVID-19:

  • It is compatible with standard vaccine distribution channels
  • It has good efficacy numbers as a single-dose vaccine
  • It can be stored at least three months in most standard refrigerators

Based on Phase III efficacy data released from the ENSEMBLE study on January 29, Janssen’s single-dose vaccine was:

  • 72% effective in the U.S.
  • 66% effective overall at preventing moderate to severe COVID-19 illness 28 days after vaccination
  • 85% effective overall in preventing severe disease
  • Demonstrated 100% protection against COVID-19 related hospitalization and death on Day 28

Janssen, a division of Johnson & Johnson, used their AdVac vaccine technology platform to develop the vaccine; this platform is the same one the company used for developing and manufacturing its European Commission-approved Ebola vaccine regimen, as well as for constructing the investigational Zika, RSV, and HIV vaccines. Over 200,000 people have already received vaccines based on this platform.

AMA Prepares for Authorization

The AMA has already created a pair of vaccine administration/toxoid codes for use in reporting this Johnson & Johnson/Janssen Biotech vaccine:

  • 91303 – Janssen Biotech’s COVID-19 vaccine TOXOID
  • 0031A – ADMINISTRATION of single dose of Janssen Biotech’s vaccine

These codes will become effective on the date of the FDA’s EUA of the vaccine.

Context4 Healthcare Customers Stay in the Loop

As always, our products will include the latest rules and codes according to industry updates.

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